NCT07133568

Fun Exercise Intervention for Older Adults to Improve Intrinsic Capacity and Motivation

Design, Development, and Validation of a Recreational Exercise Intervention in Older Adults to Improve Intrinsic Capacity and Motivation: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Cardenal Herrera University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This randomized clinical trial aims to evaluate the effectiveness of a structured, multicomponent recreational exercise program (FEXO: Fun Exercise for Older Adults) in improving intrinsic capacity, motivation, and adherence among community-dwelling older adults. Participants aged 60 years and older will be randomly allocated to either the FEXO group or a control group performing the established OTAGO program. The intervention will last 14 weeks, with three weekly sessions. Assessments will be conducted at baseline, post-intervention, and after a 3-month follow-up.

Detailed description

The global increase in the aging population poses significant public health and societal challenges, particularly regarding multimorbidity, frailty, and functional decline. In response, the World Health Organization has introduced the concept of Intrinsic Capacity (IC), which encompasses the physical and mental capacities an individual can draw upon. IC includes five domains: locomotion, vitality, cognition, psychological well-being, and sensory function. Evidence supports multicomponent exercise as a primary strategy to promote healthy aging and preserve functionality in older adults. However, low adherence and motivation remain critical barriers. This study proposes a novel, recreationally oriented multicomponent program-FEXO-designed to increase engagement through fun, low-cost, group-based sessions adapted to functional levels. The study is a two-arm, parallel-group, randomized clinical trial with a 2:1 allocation ratio (intervention:control). A total of 122 older adults from the community will be recruited and randomized into either the FEXO group or the control group (OTAGO program). Both interventions include three non-consecutive weekly sessions over 14 weeks. The FEXO program includes a familiarization phase and progressive intensity adjustments. Sessions integrate strength, balance, coordination, cognitive stimulation, and relaxation in a recreational format using music, elastic bands, and playful materials. Primary outcomes include changes in Intrinsic Capacity, assessed through standardized tools across its five domains. Secondary outcomes include anthropometric data, cardiovascular parameters, physical performance tests, cognitive function, depression, resilience, and exercise motivation. Adherence will be tracked as the percentage of sessions attended. Statistical analysis will be conducted on an intention-to-treat basis using two-way ANOVA, with effect sizes and confidence intervals reported. The study has been approved by the Ethics Committee of CEU Cardenal Herrera University and complies with the Declaration of Helsinki.

Conditions

• Sarcopenia
• Frailty Syndrome

Interventions

Type	Name	Description
OTHER	Fun Exercise for Older Adults (FEXO)	The FEXO (Fun Exercise for Older Adults) program is a 14-week, multicomponent, recreational exercise intervention designed to enhance intrinsic capacity, motivation, and adherence in community-dwelling older adults. Participants engage in three non-consecutive, supervised group sessions per week (maximum instructor-to-participant ratio 1:15), each lasting approximately 60 minutes. The program begins with a two-week familiarization phase followed by three progressive phases (4 weeks each), with exercise intensity, repetitions, and resistance levels adjusted based on functional performance assessed by the Short Physical Performance Battery (SPPB).
OTHER	OTAGO	The OTAGO Exercise Program is a structured, evidence-based intervention developed to improve lower-limb strength and balance and reduce fall risk in older adults. In this study, participants in the control group will complete three non-consecutive, supervised sessions per week for a total duration of 14 weeks. Sessions will be delivered in group settings under the supervision of a licensed physiotherapist. The program includes individualized strength training for the lower extremities, progressive balance exercises, and walking routines. Although originally designed as a home-based program, in this trial it will be implemented in indoor, climate-controlled, non-slip-floor facilities provided by local institutions. The OTAGO protocol does not include recreational, cognitive, or playful components, serving instead as a standard, structured intervention against which the FEXO program will be compared.

Timeline

• Start date: 2025-09-04
• Primary completion: 2025-12-19
• Completion: 2025-12-31
• First posted: 2025-08-21
• Last updated: 2026-04-08

Locations

1 site across 1 country: Spain